instruction for use asskea ped m and asskea ped s

GA14-15 / Revision B-1 / 01.2019

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008)

Instruction for use

ASSKEA ped M and ASSKEA ped S

0843


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Copyright © 2019 ASSKEA GmbH, Gebesee.

The safety of the ASSKEA ped M resp. ASSKEA ped S complies with the acknowledged rules of

technology and meets the requirements of the German Medical Devices Act.

The devices ASSKEA ped M and ASSKEA ped S bear the CE marking CE0843 in accordance with

EU Council Directive 93/42/EEC concerning medical devices and meet the essential requirements

of Annex I of this directive.

The ASSKEA ped M and the ASSKEA ped S have been tested in accordance with IEC 62353.

The quality management system applied by ASSKEA GmbH is certified in compliance with the

relevant international standards.

The devices ASSKEA ped M and ASSKEA ped S are medical suction devices classified as class IIa

in accordance with EU Council Directive 93/42/EEC, Annex IX.

Errors and omissions excepted.

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Contents 1 User information .................................................................................................................. 5

1.1 Using this instruction for use ................................................................................................... 5 1.2 Icons ............................................................................................................................................. 5

1.2.1 General symbols ................................................................................................................... 5 1.2.2 Devices and packaging......................................................................................................... 5 1.2.3 Display .................................................................................................................................... 6

1.3 Symbol convention .................................................................................................................... 6 1.4 Glossary ....................................................................................................................................... 7 1.5 Purpose ....................................................................................................................................... 8

1.5.1 Intended use ......................................................................................................................... 8 1.5.2 Essential features ................................................................................................................. 8 1.5.3 Applied parts ......................................................................................................................... 8 1.5.4 Indications ............................................................................................................................. 8 1.5.5 Contraindications ................................................................................................................. 8 1.5.6 Restrictions on use ............................................................................................................... 8

1.6 Basic safety instructions ........................................................................................................... 9 1.7 User requirements ................................................................................................................... 11 1.8 Information on product liability ............................................................................................. 11 1.9 Material compatibility.............................................................................................................. 11

2 Product description ............................................................................................................ 12 2.1 Whole view ................................................................................................................................ 12

2.1.1 ASSKEA ped M ..................................................................................................................... 12 2.1.2 Product contents ASSKEA ped M ...................................................................................... 12 2.1.3 ASSKEA ped S disposable secretion canister system .................................................... 13 2.1.4 Product contents ASSKEA ped S disposable secretion canister system ..................... 13 2.1.5 ASSKEA ped S reusable secretion canister system ........................................................ 14 2.1.6 Product contents ASSKEA ped S reusable secretion canister system ......................... 14

2.2 Product properties ................................................................................................................... 15 2.2.1 Disposable secretion canister for ASSKEA ped M .......................................................... 16 2.2.2 Information on the ASSKEA filter system for the ASSKEA ped M ................................. 16 2.2.3 Information on the carbon filter of the ASSKEA ped M ................................................. 16 2.2.4 Secretion canister systems for ASSKEA ped S ................................................................ 17 2.2.5 Information on the double filter system for ASSKEA ped S .......................................... 17 2.2.6 Information on the battery ............................................................................................... 18 2.2.7 Pressure settings ................................................................................................................ 18

2.3 Warranty ................................................................................................................................... 19 3 Operation ............................................................................................................................ 20

3.1 Set-up and startup ................................................................................................................... 20 3.1.1 Startup ................................................................................................................................. 20 3.1.2 Connecting the ASSKEA ped M resp. ASSKEA ped S ...................................................... 21 3.1.3 Positioning of the ASSKEA ped M ..................................................................................... 21 3.1.4 Connecting the disposable secretion canister for ASSKEA ped M ............................... 22 3.1.5 Positioning of the ASSKEA ped S ...................................................................................... 23 3.1.6 Connecting the disposable secretion canister system for ASSKEA ped S ................... 23 3.1.7 Connecting the reusable secretion canister system for ASSKEA ped S ...................... 26

3.2 Operation of the ASSKEA ped M and the ASSKEA ped S .................................................... 28 3.2.1 Operation at initial startup ................................................................................................ 28 3.2.2 Language selection ............................................................................................................. 28

3.3 Patient mode ............................................................................................................................ 29 3.4 Canister exchange ................................................................................................................... 30

3.4.1 Replacement of the disposable canister of the ASSKEA ped M ................................... 30

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3.4.2 Replacement of the disposable liner “OneWay” of the ASSKEA ped S ........................ 30 3.5 Decommissioning .................................................................................................................... 31

4 Maintenance ....................................................................................................................... 32 4.1 Cleaning and care .................................................................................................................... 32

4.1.1 General information ........................................................................................................... 32 4.1.2 Cleaning and disinfection of the surface of the devices ............................................... 33 4.1.3 Disposal of the disposable secretion canister for ASSKEA ped M ............................... 33 4.1.4 Disposal of the disposable liner “OneWay” and the suction tube for ASSKEA ped S 33 4.1.5 Cleaning/disinfection of the external canister “Bag” for ASSKEA ped S ...................... 33 4.1.6 Cleaning/disinfection of the reusable secretion canister system for ASSKEA ped S . 34 4.1.7 Cleaning/disinfection of the connecting tube for ASSKEA ped S ................................. 34

4.2 Maintenance and service ........................................................................................................ 35 4.3 Inspection of the ASSKEA ped M resp. ASSKEA ped S ......................................................... 35

5 Problem solving .................................................................................................................. 36 5.1 Function test ............................................................................................................................. 36 5.2 Troubleshooting ....................................................................................................................... 36 5.3 Error messages ........................................................................................................................ 37

6 Transport, storage and disposal ....................................................................................... 39 6.1 Decontamination prior to shipment ..................................................................................... 39 6.2 Storage ...................................................................................................................................... 39 6.3 Disposal ..................................................................................................................................... 39

7 Technical data ..................................................................................................................... 40 7.1 ASSKEA ped M .......................................................................................................................... 40 7.2 ASSKEA ped S ............................................................................................................................ 41 7.3 EMC information ...................................................................................................................... 42

8 Ordering information ......................................................................................................... 47 8.1 ASSKEA ped M .......................................................................................................................... 47 8.2 ASSKEA ped S ............................................................................................................................ 47

9 Publishing information ...................................................................................................... 48

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1 User information

1.1 Using this instruction for use

Please read this entire instruction for use before operating the device ASSKEA ped M resp.

ASSKEA ped S for the first time.

Please read the safety instructions (chapter 1.6) to avoid hazards.

This instruction for use is a component of the ASSKEA ped M resp. ASSKEA ped S. Keep this

instruction for use therefore in an easily accessible location.

Include this instruction for use when passing the device ASSKEA ped M resp. ASSKEA ped S on

to third parties.

1.2 Icons

1.2.1 General symbols

Symbol Meaning Symbol Meaning

Attention: possible bodily

injury, health risk or possible

property damage

NOTE

Note containing useful

information and tips.

1.2.2 Devices and packaging

Symbol Meaning Symbol Meaning

Protect from moisture

Order number

Protection class II

Serial number

Humidity limitation

Lot number

Air pressure limitation

Date of manufacture

Follow the instruction for use

Manufacturer

Protection class: Type BF

(Body Floating)

Do not use, if packaging is

damaged!

Temperature limitation

Do not reuse.

This device must not be

disposed of in domestic waste. Power supply unit

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1.2.3 Display

Symbol Meaning

Battery full

Battery low

Battery empty

Up

Down

OK (On, Enter)

Cancel (Off, Back)

Power supply unit is connected

Filter run time elapsed; replacement of the internal filter by service is

required!

1.3 Symbol convention

Symbol Meaning

• Enumeration

1.

2. Perform the process in the specified order.

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1.4 Glossary

A

Aspirate

C

Aspirate is the generic term for secretions, bodily fluids and flushing liquids

that are typically accumulated during aspiration of the upper airways. These

can be aspirated easily using the devices described here.

Contamination

D

Contamination means that bacteria and viruses from the aspirate have come

into contact with the devices.

Degree of

protection

I

The degree of protection indicates the protection of applied parts against

electric shock. Applied parts of type BF have to be installed isolated from

earth and are not suitable for direct application to the heart.

incl.

IP22

M

Abbreviation for “including”

International Protection/Protection Class

The Protection Class specifies the degree of protection of the devices against

contact and ingress of liquids.

The devices ASSKEA ped M and ASSKEA ped S are protected against finger

access and falling water drops at an inclination of up to 15°.

ME

MRI

O

Medical electrical

Abbreviation for “magnetic resonance imaging”

This technique generates sectional images of the human body with the aid of

a very strong magnetic field for the purpose of analyzing the organs.

Overflow

P

Overflow means that aspirate is sucked into the interior of the devices.

Processing

R

The processing procedure is required for each new patient. The term

processing means that all parts that have (potentially) come into contact with

the aspirate must be replaced.

Processing may only be performed by ASSKEA GmbH or by a service partner

authorized by ASSKEA GmbH.

resp. Abbreviation for “respectively”

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1.5 Purpose

1.5.1 Intended use

The ASSKEA ped M and the ASSKEA ped S are network-independent mobile medical aspirators

and serve for temporary and primarily spontaneous aspiration of aspirate from the trachea. The

ASSKEA ped M and the ASSKEA ped S are especially designed for the secretion aspiration of

children and can be used in outpatient and inpatient care (professional healthcare facility

environment).

1.5.2 Essential features

Generation of vacuum (medium vacuum)

Generation of flow (low flow)

1.5.3 Applied parts

There are no applied parts; however housing and suction tube are considered as applied parts of

type BF.

1.5.4 Indications

Tracheostomy patients

Aspiration on impaired respiratory function

Aspiration on blood, secretion and food residues from the oral cavity, the pharyngeal zone

and the bronchial system

1.5.5 Contraindications

The ASSKEA ped M and the ASSKEA ped S are contraindicated for the following applications:

Liposuction

Gynecology applications

Dental applications

Thoracic drainage

Continuous drainage

Applications in wound areas

1.5.6 Restrictions on use

in medical rooms where potential equalization is required (e.g. heart surgery)

in hazardous areas/in the MRI environment

outdoors/during transport

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1.6 Basic safety instructions

Warning of damage due to improper power supply

Improper operation causes overvoltage in the devices, which may be transmitted to the

operator.

Ensure prior to startup that the mains supply for connecting the ASSKEA ped M resp.

ASSKEA ped S is suitable at 100 V to 240 V AC and a mains frequency of 50-60 Hz.

Ensure prior to startup in UL listed markets such as the USA and Canada that the mains

supply is designed for a supply voltage of 120 V AC.

Only use the supplied power supply unit (type: FRIWO FW7555M/12, FRIWO Gerätebau

GmbH) with the device ASSKEA ped M resp. ASSKEA ped S.

Risk of application under conditions that are not approved

The devices are not intended to be used in medical rooms where potential equalization is

required (e.g. heart surgery).

The devices are not intended to be used in hazardous areas/in the MRI environment.

The devices are not intended to be used outdoors/during transport.

Health risks due to the handling of infectious or pathogenic germs

Infectious and pathogenic germs in the aspirate cause health risks.

Always perform the aspiration using a suitable sterile disposable catheter. The suction tube

must never come into direct contact with the aspiration site.

Follow the hygiene, cleaning and decontamination instructions.

Hazard of persons due to strangulation

People may strangle themselves on the tubing or the mains cable, especially if tubes resp.

cables are unduly long.

Ensure that no unauthorized/uninvolved persons are near the devices during aspiration.

Store the devices incl. accessories in the shipping carton until the next time of use.

Risk of damage due to electromagnetic phenomena

Medical electrical devices are subject to special precautionary measures regarding

electromagnetic compatibility and must be installed and operated in accordance with the EMC

information provided in the accompanying documents (see chapter 7.3).

Hazard of persons due to improper handling

Only use the devices for their intended purpose.

Never use the devices for aspiration in the low vacuum range (e.g. thoracic drainage).

If aspiration procedures are carried out too often, slight bleeding may occur.

When using the power supply unit, ensure that it is connected to the aspirator firstly and

afterwards to the mains supply (100 V to 240 V AC).

The disconnection of the power supply unit from the mains supply must be performed in

exactly the opposite sequence (first remove the power supply unit from the mains supply

(100 V to 240 V AC) and then remove it from the aspirator).

Damage of the devices by heat

Do not cover the power supply unit.

Keep the aspirators as well as the mains cable and the power supply unit away from other

heat sources.

Do not place the aspirators directly adjacent to other devices, since this can result in heavy

warming of the aspirators.

Safety defects due to improper accessories and spare parts

The use of accessories and spare parts, detachable parts or materials that are not

recommended by ASSKEA GmbH and specified in the instruction for use may compromise the

safety and function of the devices. Any warranty is excluded for damage caused by using

accessories and spare parts not recommended or by improper use.

Only use the recommended original accessories and spare parts.

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Warning of safety defects due to improper connections of the ME system

The connection of the ME system with other devices or installations resp. pieces of equipment

not recommended by ASSKEA GmbH and not specified in the instruction for use may

compromise the safety and function of the ME system. Any warranty is excluded for damage

caused by connecting devices or installations resp. pieces of equipment not recommended with

the ASSKEA ped M resp. ASSKEA ped S or by improper use.

Only connect recommended original parts with the ASSKEA ped M resp. ASSKEA ped S.

Damage of the devices due to improper handling

Never aspirate flammable, corrosive or explosive liquids or gases.

Do not drop the devices.

Prior to each use check the housing for any damage and do not operate the devices in case of

apparent housing damage.

Prior to each use check the suction tube and the secretion canister and, if applicable, any

other accessories that are subject to wear and damage, to ensure that the components are in

a perfect condition and proper operation of the devices is guaranteed. If this is not the case,

replace the parts immediately.

Damage of the devices by ingress of liquids

The devices ASSKEA ped M and ASSKEA ped S have the IP classification IP22 against the ingress

of liquids. Nevertheless protect the devices from moisture.

Do not use the devices near splashing water.

Do not use the devices in damp rooms or while bathing or showering.

Avoid wet conditions on power supply unit, display foil and socket for the power supply unit.

Never submerge the devices in water or other liquids (also not while they are switched off).

Possible physiological effects and unobvious risks

Select the vacuum depending on the respective patient and on the medical indication to

avoid personal injuries.

Always place the devices upright on a sturdy and flat base without slope. Make sure that the

devices cannot be knocked over or fall in such a way that persons could be hit by a falling

device.

Other devices, examinations or treatments may possibly be influenced by the devices. For

this reason, special attention should always be paid to other devices as well as to

examinations and treatments performed in parallel so that any influence is detected as quick

as possible.

When using the devices, adequate lighting must always be ensured so that all labels can be

identified clearly.

Small, detached parts could be inhaled or ingested. Therefore ensure that no unauthorized

persons, children or pets are near the devices.

Although the materials used have been tested for compatibility, in exceptional cases allergic

reactions to the exposed materials on the devices and their accessories may occur. This

applies especially for contact injuries after prolonged contact. In such cases, turn to a doctor

immediately.

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1.7 User requirements

The ASSKEA ped M and the ASSKEA ped S may only be operated and used by

instructed and appropriately trained persons. Familiarize yourself with the mode

of operation of the ASSKEA ped M resp. ASSKEA ped S prior to startup.

Training on how to handle the ASSKEA ped M resp. ASSKEA ped S is provided by ASSKEA GmbH

or an authorized distribution partner of ASSKEA GmbH. Product training takes approximately one

to two hours and, among other things, includes an explanation of the design and function of the

devices, the handling of the devices, the cleaning and disinfection as well as the procedure to be

followed for each new patient and for disposal.

The training should be repeated regularly every 24 months.

Each participant receives a certificate as proof of training.

1.8 Information on product liability

The liability for the operation of the devices is channeled to the operator in the following cases:

the devices are used outside their intended use,

the devices are not used according to the instruction for use,

the devices are opened by unauthorized personnel,

the security seal is removed/damaged,

installation, settings, enhancements, maintenance or repairs are performed by unauthorized

personnel,

original accessories and spare parts are not used,

the devices are used beyond their service life of 5 years.

Advice for the responsible organization:

The assembly of ME systems and modifications during their actual service life shall be evaluated

based on the requirements of the applying standards.

1.9 Material compatibility

Aggressive substances may damage the devices and the accessories.

Please follow the cleaning and care instructions (chapter 4.1)

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2 Product description

2.1 Whole view

2.1.1 ASSKEA ped M

Fig. 1

Fig. 2

A disposable secretion canister (250 ml)

with integrated suction tube

B canister locking mechanism

C (on) and (off) buttons

D display

E (up) and (down) arrow buttons

F device ASSKEA ped M

G socket for power supply unit

2.1.2 Product contents ASSKEA ped M

the device ASSKEA ped M

2 x disposable secretion canister (250 ml) with integrated bacterial filter, carbon filter,

solidifier and suction tube

power supply unit (type: FRIWO FW7555M/12) incl. country adapter

instruction for use

charging instructions, multilingual

“Used Medical Device” label and decontamination certificate

test report in accordance with IEC 62353

instructions for safe handling of battery packs

optional accessories (depending on the order)

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2.1.3 ASSKEA ped S disposable secretion canister system

Fig. 3

A

external canister “Bag” and disposable

liner “OneWay” (1,000 ml)

B holder for external canister “Bag”

C connecting tube

D display

E control panel

( (on) and (off) buttons, (up)

and (down) arrow buttons)

F device ASSKEA ped S


2.1.4 Product contents ASSKEA ped S disposable secretion canister system

the device ASSKEA ped S

disposable secretion canister system

(comprising the external canister “Bag”, disposable liner “OneWay”, holder for external

canister “Bag”, connecting tube and disposable suction tube (sterile))


instruction for use






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2.1.5 ASSKEA ped S reusable secretion canister system

Fig. 3-1

A

secretion canister (reusable) with

integrated overflow protection in

the lid (see fig. 17)

B bacterial filter (external)

C connecting tube

D display

E control panel

( (on) and (off) buttons,

(up) and (down) arrow buttons)

F device ASSKEA ped S


2.1.6 Product contents ASSKEA ped S reusable secretion canister system

the device ASSKEA ped S

reusable secretion canister system

(comprising the reusable secretion canister, S6 lid with ball for overflow protection, bacterial

filter, connecting tube, tube mount and disposable suction tube (sterile))


instruction for use






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2.2 Product properties


Only use the devices for their intended purpose.

Never use the devices for aspiration in the low vacuum range

(e.g. thoracic drainage).

Damage to the device due to improper handling

Never aspirate flammable, corrosive or explosive liquids or gases.

Do not drop the devices.

Do not operate the devices in case of apparent housing damage.

The devices ASSKEA ped M and ASSKEA ped S are especially handy, battery powered medical

aspiration devices for stationary and mobile use.

The ASSKEA ped M and the ASSKEA ped S have a flow rate of max. 8 l/min (see chapter 7

“Technical data”).

The ASSKEA ped M and the ASSKEA ped S are operated via the internal battery or via the

supplied power supply unit that can also be used to recharge the battery. The desired vacuum is

generated by a maintenance-free electric motor driven membrane pump.

After it is switched on, the vacuum pump generates a vacuum in the tubing system and in the

secretion canister system, which is used to aspirate secretion (via a suitable sterile suction

catheter). The aspirate is directed away from the patient and collected in the secretion canister.

If the secretion canister is full, the devices trigger an alarm via an integrated overflow protection

and stop the pump. The device ASSKEA ped M can only be operated with the supplied

disposable secretion canister. The device ASSKEA ped S can be operated with the supplied

disposable secretion canister system as well as with the reusable secretion canister system,

which is also available.

The expected service life of the ASSKEA ped M resp. ASSKEA ped S is 5 years. The provided

disposable secretion canister for the ASSKEA ped M as well as the disposable liner “OneWay” and

the suction tube for the ASSKEA ped S are intended for single use.

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2.2.1 Disposable secretion canister for ASSKEA ped M

The disposable secretion canister consists of a canister with a connected suction tube. The

disposable secretion canister has an integrated bacterial filter, carbon filter and solidifier. The

hydrophobic bacterial filter integrated in the disposable secretion canister is 99 % effective

against bacteria and viruses. This integrated filter prevents an overflow in the event of an

operational error. If liquid reaches this filter, aspiration is no longer possible and the error

message “System closed/canister full” appears on the display. The aspiration process is

discontinued. The disposable secretion canister must be replaced.

The activated carbon filter in the disposable secretion canister reduces the spread of odor.

Solidifier:

Disposable secretion canisters filled with aspirate can be transported and disposed in a leak-

proof manner by using the solidifier. The aspirate solidifies after an average gelling time of 2 to 5

minutes (depending on the consistency of the aspirate), irrespectively of the aspiration intervals.

The disposable secretion canister incl. suction tube is intended for single use.

Replace the disposable secretion canister in accordance with the respectively applicable

hygiene instructions, if it is full, prior to each new patient or weekly at the latest.

2.2.2 Information on the ASSKEA filter system for the ASSKEA ped M

The filter system of the ASSKEA ped M consists of the external bacterial filter integrated in the

disposable secretion canister and the internal filter installed in the device. The internal filter is a

self-sealing bacterial filter and is 99.999 % effective against bacteria and viruses in combination

with the filter integrated in the disposable secretion canister.

The ASSKEA filter system effectively protects the interior of the device from

contamination and overflow.

Service life and reuse

The internal filter of the ASSKEA filter system is not intended for reuse. To ensure

consistent performance, the internal filter must be replaced after contact with the

aspirate (blocked), after the filter service life has expired ( symbol in the display)

or during maintenance/ repair.

The internal filter must be replaced by ASSKEA GmbH or an authorized service partner of

ASSKEA GmbH.

2.2.3 Information on the carbon filter of the ASSKEA ped M

An additional filter in the exhaust air vent of the ASSKEA ped M removes undesirable odor out of

the exhaust air of the device. This filter consists of a thin activated carbon coated nonwoven. The

activated carbon in the nonwoven adsorbs the odor particles of the exhaust air and neutralizes

them. Spreading of odor will be effectively reduced.


The carbon filter is not intended for reuse. To ensure consistent performance, the carbon

filter must be replaced during maintenance/repair or after 2 years at the latest.

The carbon filter must be replaced by ASSKEA GmbH or an authorized service partner of

ASSKEA GmbH.

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2.2.4 Secretion canister systems for ASSKEA ped S

Disposable secretion canister system:

The disposable secretion canister system consists of the external canister “Bag”, the holder for

the external canister “Bag”, the disposable liner “OneWay”, the connecting tube and the suction

tube. The disposable liner “OneWay” has an integrated bacterial filter, carbon filter and solidifier.

The self-sealing bacterial filter integrated in the disposable liner “OneWay” is 99 % effective

against bacteria and viruses. This integrated filter prevents an overflow in the event of an

operational error. If the liquid reaches this filter, aspiration is no longer possible and the error

message “System closed/canister full” appears on the display. The aspiration process is

discontinued. The disposable liner “OneWay” must be replaced.

The activated carbon filter in the disposable liner “OneWay” reduces the spread of odor.

Solidifier:

Disposable liners “OneWay” filled with aspirate can be transported and disposed in a leak-proof

manner by using the solidifier. The aspirate solidifies after an average gelling time of

2 to 5 minutes (depending on the consistency of the aspirate), irrespectively of the aspiration

intervals.

The disposable liner “OneWay” and the suction tube are intended for single use.

Replace the disposable liner “OneWay” incl. suction tube in accordance with the

respectively applicable hygiene instructions, if it is full, prior to each new patient or weekly

at the latest.

Reusable secretion canister system:

The reusable secretion canister system consists of a reusable secretion canister, a canister lid

with integrated overflow protection, a suction tube and a connecting tube with external bacterial

filter. The external bacterial filter is 99 % effective against bacteria and viruses. It prevents an

overflow in the event of an operational error. If liquid reaches this filter, aspiration is no longer

possible and the error message “System closed/canister full” appears on the display. The

aspiration process is discontinued. The external bacterial filter must be replaced.

The reusable secretion canister is intended for multiple use. Replace the external

bacterial filter in accordance with the respectively applicable hygiene instructions, every

two weeks at the latest or prior to each new patient.

2.2.5 Information on the double filter system for ASSKEA ped S

The ASSKEA double filter system DFS®

consists of the external bacterial filter integrated in the

disposable liner “OneWay” resp. the external bacterial filter of the reusable secretion canister

system and the internal filter installed in the device. The filters are hydrophobic and self-sealing

bacterial filters, which, in combination, are 99.999 % effective against bacteria and viruses.

The ASSKEA double filter system DFS®

effectively protects against overflow and

contamination of the interior of the device. It permits fast, simple and cost-effective

processing.


The internal filter of the ASSKEA double filter system DFS®

, the external bacterial filter as

well as the disposable liner “OneWay” are not intended for reuse. To ensure consistent

performance, the bacterial filters must be replaced after contact with the aspirate

(blocked), after the filter service life has expired ( symbol in the display) or during

maintenance/repair.

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The internal filter must be replaced by ASSKEA GmbH or an authorized service partner of

ASSKEA GmbH.

2.2.6 Information on the battery

Inspection of the internal power supply

Since the internal battery is not maintained automatically in a fully operational

state, it is necessary to check the charging status regularly and, if necessary, the

battery must be replaced by service staff. The battery may only be replaced by

trained service staff, since the replacement by inadequately trained personnel

could result in a hazard (such as excessive temperatures, fire or explosion)!

The charge level of the battery is shown in the display.

It is strongly recommended to fully charge the battery prior to the first startup of the devices

ASSKEA ped M and ASSKEA ped S and to repeat this after the first uses.

The ASSKEA ped M and the ASSKEA ped S are equipped with a lithium-ion battery, which unlike

traditional types of rechargeable batteries has a low self-discharge rate.

The devices ASSKEA ped M and ASSKEA ped S should ideally be stored and charged at room

temperature in accordance with the ambient conditions specified in the technical data. Never

store the devices incl. battery in a discharged state!

Fully recharge the battery if the devices are not operated for a longer period of time (approx.

10 months).

Lithium-ion rechargeable batteries do not have a memory effect. Therefore they can and should

be recharged at any time after initial charging. Only frequent short-time charging should be

avoided.

The battery of the devices ASSKEA ped M and ASSKEA ped S is protected against deep

discharge, nevertheless the charging information listed above must be followed. The battery is

also protected against overheating during charging. If the battery temperature is exceeded

during charging due to improper ambient conditions, charging is temporarily discontinued to

allow cooling. The purpose of this measure is to ensure safe operation and to protect the battery.

The typical service life of the battery amounts to approx. 300 load cyles, subsequently more than

80 % of the primary capacity are still available.

2.2.7 Pressure settings

Once the ASSKEA ped M and the ASSKEA ped S have been switched on, the pressure settings

can be individually adjusted by a healthcare professional.

Pressure settings can be adjusted in the range from -60 mbar to -350 mbar (in steps of 5 mbar).

The setting of the pressure values is described in chapter 3.2.1.

Always use the lowest possible pressure setting. Adjustments to device settings must only

be made, if instructed to do so and only by healthcare professionals.

Prior to switching on the ASSKEA ped M resp. ASSKEA ped S it must be ensured that the

device is equipped with the belonging secretion canister.

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2.3 Warranty

WARNING: Modifications of the ME devices are not permitted.

The devices ASSKEA ped M and ASSKEA ped S are covered by warranty for 2 years. It is neither

extended nor renewed by warranty work. The battery is covered by warranty for 6 months.

Wearing parts are excluded from the warranty.

ASSKEA GmbH is responsible for impacts on safety, reliability and specific performance, only if:

original ASSKEA accessories and spare parts are used,

maintenance and repair are performed by professionals authorized by ASSKEA GmbH or by

ASSKEA GmbH itself,

the ASSKEA ped M and the ASSKEA ped S are used and operated in accordance with the

instruction for use and within their intended use.

All warranty claims shall be void, if:

the devices are opened by unauthorized personnel,

the safety seal is removed/broken,

repairs are performed by unauthorized personnel,

modifications are made to the devices,

since the basic safety of the devices can no longer be guaranteed in these cases

and functional limitations may occur.

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3 Operation


Please read through chapters 3.1 and 3.2 carefully!

The ASSKEA ped M and the ASSKEA ped S may only be operated and used by

instructed and appropriately trained persons.

Only use suitable sterile disposable catheters for aspiration! Commercially

available sterile disposable catheters that are intended for the use in the

tracheal area can be connected.

If aspiration procedures are carried out too often, slight bleeding may occur.

Malfunction due to aspirated secretion

Empty the reusable secretion canister when it is half-full to curtail frothing. If

the reusable secretion canister is full, the mechanical overflow protection is

triggered. This disrupts the aspiration process.

Switch off the device when emptying the reusable secretion canister.

If secretion has been aspirated into the device, it must be properly processed

by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH!

Damage of the devices due to insufficient acclimatization

After the devices have been exposed to temperatures between -10°C and +60°C

during transport/storage according to the technical data (see chapter 7), they

must firstly acclimatize for ca. 2 h at room temperature (ca. 20°C) before the

intended use is possible.

3.1 Set-up and startup

3.1.1 Startup

It is important to follow the safety instructions in chapter 1.6 prior to initial startup.

Always have one backup disposable secretion canister for the ASSKEA ped M and one backup

disposable liner „OneWay“ for the ASSKEA ped S ready, since these are absolutely necessary for

safe operation!

Please read this entire instruction for use before operating the device ASSKEA ped M resp.

ASSKEA ped S for the first time.

Remove device and accessories from the packaging.

Always place the devices on a sturdy and flat surface without slope, take care of the correct

position of the devices.

Inspect all tubing as well as the power supply unit for damage prior to each startup of the

ASSKEA ped M resp. ASSKEA ped S. It is important to avoid kinking when connecting the

tubes. Ensure prior to switching on the unit that the secretion canister and the tubing are

properly connected.

Fully charge the battery prior to initial startup.

Perform a function test! (see chapter 5.1)

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3.1.2 Connecting the ASSKEA ped M resp. ASSKEA ped S

Use the socket for the power supply unit of the ASSKEA ped M (chapter 2.1.1, fig. 1/2(G)) resp.

the socket for the power supply unit of the ASSKEA ped S (chapter 2.1.3, fig. 3(G)) to connect the

devices to the mains power supply via the supplied power supply unit (type: FRIWO FW7555M/12)

for charging or operation as required.

Use the supplied power supply unit only. First connect the power supply unit to the socket for the

power supply unit of the ASSKEA ped M resp. ASSKEA ped S and then to the mains power

supply.

3.1.3 Positioning of the ASSKEA ped M

The ASSKEA ped M can be placed next to the patient bed or attached by means of a variable

holder for tube and rail systems. An optional carrying bag is available for portable use. It is,

however, up to the physician to decide whether the condition of the patient permits portable use.

The ASSKEA ped M can also be used in a horizontal position according to the following figure:

Fig. 4 ASSKEA ped M horizontally

To ensure optimum aspiration, place the ASSKEA ped M below the patient to be treated.

It should be noted that the suction tube does not form a dip and is situated at least on

patient level.

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3.1.4 Connecting the disposable secretion canister for ASSKEA ped M

Fig. 5 Connecting the disposable secretion canister

A Disposable secretion canister incl. suction tube

B Locking mechanism for canister

C Aspiration port

D ASSKEA ped M

E Guiding rail

1. Remove the disposable secretion canister (fig. 5(A)) from the packaging.

2. Slide the canister on the guiding rail (fig. 5(E)) of the ASSKEA ped M until the disposable

secretion canister clicks into place in the locking mechanism (fig. 5(B)).

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3.1.5 Positioning of the ASSKEA ped S

The ASSKEA ped S can be placed next to the patient bed. Optionally a variable holder for the

attachment of the device to tube and rail systems as well as a bed holder are available.

To ensure optimum aspiration, place the ASSKEA ped S below the patient to be treated.

It should be noted that the suction tube does not form a dip and is situated at least on

patient level.

3.1.6 Connecting the disposable secretion canister system for ASSKEA ped S

Malfunction due to collapsing disposable liner “OneWay”

A leak in the external canister “Bag” or at the lid of the disposable liner

“OneWay” may cause air to flow into the external canister “Bag”. This may lead

to the collapse of the disposable liner “OneWay”.

Inspect the disposable secretion canister system (1,000 ml) to ensure that

the lid of the disposable liner “OneWay” is firmly connected to the external

canister “Bag”.

Ensure that all connections are firmly attached and properly connected.

Ensure that the external canister “Bag” is undamaged and the T-piece is

firmly attached.

Follow the instruction for use supplied by the manufacturer!

The original ASSKEA disposable secretion canister system consists of the external canister “Bag”,

the holder for the external canister “Bag”, the disposable liner “OneWay”, the connecting tube for

the disposable liner “OneWay” and the sterile disposable suction tube with step connector.

Connection designation:

A Vacuum connection

B Patient connection

Please also follow the instruction for use

supplied with the disposable secretion

canister system (1,000 ml)!

Fig. 6

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1. Remove the disposable liner “OneWay” from the packaging and fully extend it.

Fig. 7

2. Place the disposable liner “OneWay” in the reusable external canister “Bag”. Press the

lid’s edges firmly down to ensure proper sealing.

Fig. 8

3. Attach the prefitted connecting tube of the disposable liner “OneWay” to the bottom

end of the T-piece located at the external canister “Bag”.

Fig. 9

4. Connect the vacuum connection of the device with the corresponding vacuum

connection of the external canister “Bag” (top end of the T-piece). Use the supplied

connecting tube to do so.

Fig. 10

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5. Connect the patient connection of the disposable liner “OneWay” (fig. 6(B)) to the

suction tube. Ensure that the tube is fixed sufficiently tight.

Fig. 11

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3.1.7 Connecting the reusable secretion canister system for ASSKEA ped S

1. Screw the lid of the reusable secretion canister sufficiently tight and attach the canister to

the device.

2. Insert the connecting tube with the blue elbow fitting toward the side of the device. Make

sure that the side of the external bacterial filter with the lettering “IN” is facing the canister

(directed toward patient)!

Fig. 12

3. Place the grey elbow adapter of the connecting tube onto the connection in the middle of

the secretion canister lid (above the overflow protection).

Fig. 13

4. Place the suction tube onto the second connection (patient connection). Ensure that the

tube is fixed sufficiently tight.

Fig. 14

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The reusable secretion canister resp. the holder for the external canister “Bag” is attached by

directly pushing it onto the guiding rails at the housing of the device (figs. 15, 16).

Please notice that up to four mounting positions are usable for the secretion canister

(figs. 15, 16).

Fig. 15 Fig. 16

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3.2 Operation of the ASSKEA ped M and the ASSKEA ped S

3.2.1 Operation at initial startup

1. Press the button for 1-2 seconds to switch on the ASSKEA ped M resp. ASSKEA ped S.

The following start screen is displayed:

2. After 5 seconds the following screen is displayed. Two values are shown.

(preset of the target value: -100 mbar)

3. Use the arrow buttons to set the prescribed vacuum value (target value).

4. Press the button to start the pump.

5. Press the button to stop the pump.

6. Switch off the ASSKEA ped M resp. ASSKEA ped S by pressing the button for 3 seconds.

3.2.2 Language selection

The German language is the present language on the devices ASSKEA ped M and ASSKEA ped S.

To customize the language, follow these steps:


The following start screen is displayed for 5 seconds:

2. While the start screen is displayed, simultaneously press the arrow buttons. The

menu Setup language is displayed.

3. Use the arrow buttons to select the desired language.

4. Use the button to confirm your choice.

Actual value

Target value

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3.3 Patient mode

The ASSKEA ped M resp. ASSKEA ped S enables the selection of the patient mode at startup. In

the patient mode, the patient runtime can be viewed and reset.

To select the patient mode, follow these steps:


The following start screen is displayed for 5 seconds:

2. While the start screen is displayed, press and hold down the button and additionally

press the button for 1-2 seconds. The Authorization screen is displayed.

3. Use the arrow buttons to enter the code “xxxx”.

Press the arrow button until the desired digit of the code is displayed and confirm the

entry with the button. Select the other digits of the code with the arrow button and

confirm them with the button as well.

The authorization code for the patient mode may only be passed to specially

trained personnel. You receive the training and the authorization code by ASSKEA

GmbH or an authorized service partner of ASSKEA GmbH.

Passwords must be treated as confidential information to prevent misuse.

4. The patient runtime is displayed.

5. Press the button for 3 seconds to reset the patient runtime to zero.

6. Exit the patient mode by pressing the button.

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3.4 Canister exchange

3.4.1 Replacement of the disposable canister of the ASSKEA ped M

1. Switch off the ASSKEA ped M.

2. Close the tubing clamp on the suction tube.

3. Remove the suction tube from the suction catheter.

4. Press on the locking mechanism at the top of the canister (fig. 5(B)) and keep it pressed

while pulling the disposable secretion canister horizontally away from the device.

5. Dispose of the disposable secretion canister and the integrated suction tube in a proper

manner (see chapter 6.3 “Disposal”).

6. Place a new disposable secretion canister on the device. Ensure that the disposable

secretion canister is properly connected to the device.

7. Connect the suction tube to the suction catheter.

8. Switch on the ASSKEA ped M.

3.4.2 Replacement of the disposable liner “OneWay” of the ASSKEA ped S

1. Switch off the ASSKEA ped S.


3. Remove the suction tube from the suction catheter.

4. Remove the pre-assembled connecting tube of the disposable liner “OneWay” at the bottom

end of the T-piece of the external canister “Bag”.

5. Remove the disposable liner “OneWay” from the reusable external canister “Bag”.

6. Dispose of the disposable liner “OneWay” incl. the suction tube in a proper manner

(see chapter 6.3 “Disposal”).

7. Place a new disposable liner “OneWay” in the reusable external canister “Bag” as specified in

chapter 3.1.6. Ensure that the connecting tube as well as the lid of the disposable liner are

properly seated on the external canister.

8. Attach a new suction tube to the patient connection of the disposable liner “OneWay” and

connect it to suction catheter.

9. Switch on the ASSKEA ped S.

If the ASSKEA ped S is used in combination with the reusable secretion canister system,

please follow the instructions regarding cleaning/disinfection in chapter 4.1.6.

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3.5 Decommissioning



Never operate the device ASSKEA ped S in connection with the reusable

secretion canister system without external bacterial filter.

Replace the external bacterial filter every 2 weeks at the latest when used

exclusively for one patient!

Wear disposable gloves in doing so.

The reuse of bacterial filters for multiple patoents is prohibited due to safety

reasons!

For each new patient, professional hygienic processing by ASSKEA GmbH or

an authorized service partner of ASSKEA GmbH is strictly required!

Components that have come into contact with the aspirate must be cleaned,

disinfected or disposed of after each aspiration.

The disposal of aspirate and contaminated components must be performed

in a proper manner.

1. Switch off the devices after the aspiration by pressing the button for 3 seconds.

2. Remove the power supply unit from the mains supply (100 V to 240 V AC) and then

remove it from the ASSKEA ped M resp. ASSKEA ped S.

3. Remove the disposable secretion canister of the ASSKEA ped M as described in chapter

3.4.1 up to and including point 5.

4. Remove the disposable liner “OneWay” of the ASSKEA ped S as described in chapter 3.4.2

up to and including point 6. Subsequently follow the hints regarding the cleaning of the

external canister “Bag” in chapter 4.1.5. If you use the ASSKEA ped S with the reusable

secretion canister system, firstly remove the suction tube from the suction catheter and

from the secretion canister. Pull the reusable secretion canister off the guide rails on the

device and subsequently follow the hints regarding the cleaning resp. disposal of the

components of the reusable secretion canister system in chapters 4.1.6 and 4.1.7.

5. Clean the surface of the devices according to chapter 4.1.2.

6. Store the devices in the shipping carton until next operation.

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4 Maintenance

4.1 Cleaning and care

4.1.1 General information



Wear appropriate disposable gloves when replacing components that have

come into contact with the aspirate.

Use the disposable secretion canister or the disposable liner “OneWay” for

one patient only.

Replace the disposable secretion canister (ASSKEA ped M) resp. the

disposable liner “OneWay” incl. suction tube (ASSKEA ped S with disposable

secretion canister system) in accordance with the respectively applicable

hygiene instructions, if it is full, prior to each new patient or weekly at the

latest.

Replace the external bacterial filter prior to each new patient or every two

weeks at the latest (ASSKEA ped S with reusable secretion canister system).

For each new patient, professional hygienic processing by ASSKEA GmbH or

an authorized service partner of ASSKEA GmbH is strictly required!

Components that have come into contact with the aspirate must be cleaned,

disinfected or disposed of after each aspiration.

The disposal of aspirate and contaminated components must be performed

in a proper manner.

Health risks due to the handling of disinfectants

The use of appropriate disposable gloves during disinfection is

recommended.

Follow the instructions of the manufacturer of the disinfectant.

Possible bodily injury due to electric shock

Prior to cleaning/disinfection, switch off the ASSKEA ped M resp.

ASSKEA ped S.

Disconnect the power supply unit by unplugging it from the power supply.

Subsequently disconnect the power supply unit from the socket for power

supply unit of the ASSKEA ped M resp. ASSKEA ped S.

Damage of the devices due to improper cleaning agents

Do not use disinfectants that contain acetone. These may damage or

disfigure the housing components and the accessories.

Follow the instructions for use provided by the manufacturers of the utilized

disinfectants particularly with respect to material and surface compatibility

as well as the concentration information.

ASSKEA GmbH recommends “Sekusetp®

aktiv” for immersion disinfection of

the accessories and “Incidin®

Plus” respectively “Incidin®

Liquid” for wipe

disinfection of the devices.

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4.1.2 Cleaning and disinfection of the surface of the devices

Clean the surfaces of the devices on a regular basis and disinfect them in accordance

with the respectively applicable hygiene instructions, at least once a week.

Both devices can be wiped with a damp, lint-free cloth.

Follow the information on wipe disinfection provided in the previous chapter 4.1.1.

Repeated cleaning and disinfection procedures may result in minor discolorations of the plastic

housing components. However these do not affect the function of the devices.

If the interior of the devices comes into contact with liquid, the respective device must be

inspected by ASSKEA GmbH or an authorized service partner of ASSKEA GmbH.

4.1.3 Disposal of the disposable secretion canister for ASSKEA ped M

1. Close the suction tube of the disposable secretion canister by closing the tubing

clamp.

2. Dispose of the disposable secretion canister incl. suction tube in a proper manner

(see chapter 6.3).

4.1.4 Disposal of the disposable liner “OneWay” and the suction tube for ASSKEA ped S


2. Remove the pre-assembled connecting tube of the disposable liner “OneWay” at the

bottom end of the T-piece of the external canister “Bag”.

3. Remove the disposable liner “OneWay” from the external canister “Bag”.

4. Dispose of the disposable liner “OneWay” incl. suction tube in a proper manner (see

chapter 6.3).

4.1.5 Cleaning/disinfection of the external canister “Bag” for ASSKEA ped S

Please note the respectively applicable hygiene instructions. Unless otherwise directed, please

follow these steps:

1. Rinse the external canister “Bag” under running water.

2. Immerse the external canister “Bag” in disinfectant solution at the specified concentration.

3. Subsequently rinse the external canister “Bag” thoroughly and allow it to dry.

You may also autoclave the external canister “Bag” at 121°C for 20 minutes.

ASSKEA GmbH recommends replacing the external canister “Bag” every 4 weeks at the latest

and for each new patient.

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4.1.6 Cleaning/disinfection of the reusable secretion canister system for ASSKEA ped S

A reusable secretion canister lid

B overflow protection

C ball (for overflow protection)

D reusable secretion canister

Fig. 17

1. Empty the reusable secretion canister and dispose of the aspirate as well as the disposable

suction tube in a proper manner.

2. Remove the ball (overflow protection) before performing the following cleaning

instructions (fig. 17(C)) and clean resp. disinfect it separately.

3. Rinse all components of the reusable secretion canister system under running water.

4. Immerse all components of the reusable secretion canister system in disinfectant solution,

considering the specific concentration quantity. The reusable secretion canister system can

also be autoclaved at 121 °C for 20 minutes with the exception of the ball.

5. Afterwards rinse the components thoroughly and let them dry. When using an appropriate

cleaner of the manufacturer DR. WEIGERT (e.g. “neodisher AN”), the cleaning in a special

dishwasher is also possible, considering the manufacturer’s instructions.

6. Assemble the dry components according to fig. 17.

If the canister system is used and disinfected frequently, ASSKEA GmbH recommends replacing it

every 4 weeks!

4.1.7 Cleaning/disinfection of the connecting tube for ASSKEA ped S

1. Remove the external bacterial filter of the reusable secretion canister system and dispose it

in a proper manner prior to cleaning the connecting tube.

2. Rinse the connecting tube with clear water and place it int the disinfectant solution

recommended by ASSKEA GmbH for immersion disinfection.

3. Afterwards thoroughly rinse the connecting tube with clear water and let it dry!

ASSKEA GmbH recommends replacing the connecting tube every 4 weeks at the latest and for

each new patient.

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4.2 Maintenance and service

The devices ASSKEA ped M and ASSKEA ped S are maintenance-free if used according to the

instruction for use.

Perform a visual and functional inspection prior to each use (see chapter 5.1). Also include the

accessories of the devices in the inspection.

Opening the devices and repairs must only be performed by ASSKEA GmbH or by authorized

professionals of ASSKEA GmbH in compliance with the service documentation specified by the

manufacturer as well as with technical and hygienic precautionary measures.

The devices may be sent back for repair to ASSKEA GmbH directly or via the specialty dealer from

which the devices were purchased.

Clean and disinfect all accessories prior to returning the devices. The devices themselves must be

treated with a surface disinfectant. Please note the guidelines referring to decontamination

before shipping (chapter 6.1).

ASSKEA GmbH neither ensures proper functioning of the suction devices ASSKEA ped M and

ASSKEA ped S nor is ASSKEA GmbH liable for property damage or personal injury, if

- original ASSKEA accessories or spare parts are not used,

- the user instructions in this instruction for use are not followed,

- installation, settings, modifications, enhancements resp. repairs are not performed by

ASSKEA GmbH or authorized personnel of ASSKEA GmbH,

- the safety seal has been removed or is damaged.

4.3 Inspection of the ASSKEA ped M resp. ASSKEA ped S

ASSKEA GmbH offers its partners and customers fast and proper processing as well as

required testing services.

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5 Problem solving

5.1 Function test

Perform a function test of the devices without connected canister prior to use in therapy.

Perform the following steps to do so:

1. Switch on the device as described in chapter 3.2.

2. Start the therapy and allow the device to run in free flow. There must be no alarm during

60 seconds.

3. Afterwards hold the tube attachment closed with a finger and restart the therapy. The alarm

“System closed/canister full” must be displayed after no more than 5 seconds. If the alarm is

not displayed even after repeating the test, have the device inspected by a service partner.

5.2 Troubleshooting

Malfunction Probable cause Remedy

Device can not be

switched on. Battery is empty. Connect the power supply unit.

No suction

possible/no

flow of aspirate

Tubing clamp is closed.

Disposable secretion canister

(250 ml) is full.

Overflow protection is blocked.

Disposable liner “OneWay” is

full.

External bacterial filter is

blocked.

Internal filter is blocked.

Verify proper connection of the

tubing.

Replace the disposable secretion

canister (250 ml) (for ASSKEA

ped M).

Empty the reusable secretion

canister (for ASSKEA ped S).

Replace the disposable liner

“OneWay” (for ASSKEA ped S).

Replace the external bacterial filter

(for ASSKEA ped S with reusable

secretion canister system).

Please contact service!

Contact the ASSKEA GmbH or your service partner, if the malfunction cannot be corrected

by the described measures.

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5.3 Error messages

The alarms are solely system-triggered alarms, since they are identified by the

monitoring of device-specific variables.

All alarm messages (excepting “Internal error”) must be confirmed by pressing the OK

button.

Alarm messages of high priority are shown in the display with a red blinking

background and the beeper is sounded (3x, pause, 2x, 3x, pause, 2x) every 3 seconds.

Alarm messages of low priority are shown in the display with a static yellow

background and the beeper is sounded periodically (2x) every 16 seconds.

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Error message Status Probable cause Remedy

Pump off.

Discontinuation

of the current

operating mode.

- Disposable secretion canister

is full (ASSKEA ped M).

- Replace the disposable

secretion canister (ASSKEA

ped M).

- Disposable liner “OneWay” or

reusable secretion canister is

full (ASSKEA ped S).

- External bacterial filter is

blocked (for ASSKEA ped S

with reusable secretion

canister system).

-Secretion flow is disturbed

(tube kinked or stenosis in the

tube).

- Replace the disposable liner

“OneWay” or empty the

reusable secretion canister

(ASSKEA ped S).

- Replace the external

bacterial filter (for ASSKEA

ped S with reusable secretion

canister system).

- Check the tubes for kinks.

- If the alarm is displayed even

if the canister is not

connected, the internal

bacterial filter is blocked.

- Contact your service partner!

Pump off.

Discontinuation

of the current

operating mode.

Battery is empty. Connect the power supply

unit.

Pump off. Internal error.

- Shortly plug in the power

supply unit and unplug again.

- If the error reoccurs 60

seconds after restarting,

contact your service partner!

Current

operating mode

continues to run

in the

background.

Low battery charge level. Connect the power supply

unit.

(alarm after 15

minutes) Back-up

mode continues

to run in the

background.

- The therapy was not started. - Start the therapy.

- The device was not switched

off. - Switch off the device.

Contact ASSKEA GmbH or your service partner, if the malfunction cannot be corrected by

the described measures.

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6 Transport, storage and disposal

6.1 Decontamination prior to shipment

Prior to passing the ASSKEA ped M resp. ASSKEA ped S on to another patient, the devices must

be properly processed by ASSKEA GmbH or by an ASSKEA GmbH professional to protect

subsequent users and other persons. Processing is mandatory in accordance with the German

Medical Device Operator Ordinance (MPBetreibV), German Medical Devices Act (MPG) and the

manufacturer’s instructions.

ASSKEA GmbH offers its partners and customers fast and proper processing as well as required

testing services (see chapter 4).

The devices ASSKEA ped M and ASSKEA ped S must be cleaned and disinfected prior to

shipment to ASSKEA GmbH. Please follow the instructions in chapter 4.1.2! Please affix the

supplied “Used Medical Device” label to the shipping carton! Please give ASSKEA GmbH advance

notice of your product return. The product return form is provided on our internet page at

www.asskea.de.

6.2 Storage

Store the devices ASSKEA ped M and ASSKEA ped S as indicated in the technical data (see

chapter 7)!

The battery of the suction devices ASSKEA ped M and ASSKEA ped S must be charged prior to

storage of the devices. This ensures that the devices are operational at all times.

Fully recharge the battery, if the devices ASSKEA ped M and ASSKEA ped S are not used for a

longer period of time (approx. 10 months).

6.3 Disposal

The components of the devices must be disposed of properly at the end of the

product’s service life.

Ensure that the disposed components are clean and carefully sorted by material.

The housing material is labeled with a material symbol mark and is fully recyclable.

Decontaminate the devices and the accessories prior to disposal.

According to EU Directives 2012/19/EU Waste Electrical and Electronic Equipment

(WEEE) and 2011/65/EU on the restriction of the use of certain hazardous substances

in electrical and electronic equipment (RoHS II), the devices must not be disposed of

in domestic waste.

The devices and the accessories may be disposed of via ASSKEA GmbH or the service

partner.

In relation to proper disposal of potential biohazards, contact your local authority.

Outside the EU: Follow the disposal requirements of your country!

http://www.asskea.de/

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7 Technical data

7.1 ASSKEA ped M

Flow rate* (measuring point at

suction tube nozzle) max. 8 l/min (low flow)

Vacuum -60 mbar to -350 mbar (in steps of 5 mbar) (medium vacuum)

Conversion factor: 1 kPa ~ 7.5 mmHg; 1 kPa ~ 10 mbar

Canister Disposable secretion canister (250 ml)

Suction tube PVCnoDEHP suction tube with step connector, Ø 4 mm (internal),

length: 150 cm

Nominal voltage of the

power supply unit

In: AC 100 – 240 V~ / 50 – 60 Hz / 350 – 150 mA

In (UL only): 120 Vac / max. 350 mA / 50 – 60 Hz

Out: DC 12 V / 1.25 A

Maximum load current 1.25 A

Permissible input voltage 12 V

Power consumption at 12 V 15 W

Degree of protection

pursuant to IEC 60601-1 Type BF

Risk classification

pursuant to 93/42/EEC, IX IIa

Protection class

pursuant to IEC 60601-1 II

IP degree of protection IP22

CE marking CE0843

UL marking

Sound emission

Operation: 35 dB (A)

High priority alarm: 52 dB (A)

Low priority alarm: 49 dB (A)

Ambient conditions

Transport/Storage

ambient temperature: -25 °C to +60 °C

relative humidity: up to 93 %, non-condensing

air pressure: 825 hPa to 1060 hPa

Operation

ambient temperature: +5 °C to +40 °C

relative humidity: 15 % to 93 %, non-condensing


Battery, rechargeable 7.4 V; 4400 mAh (lithium ion battery)

Charging time if battery is empty 6 – 7 h

Charging time if battery is

approximately 50 % full 3 – 3.5 h

Power supply unit FRIWO FW7555M/12, FRIWO Gerätebau GmbH

Dimensions basic device (H x W x D) 165 mm x 220 mm x 90 mm

Weight (basic device) 1.2 kg

Pressure measurement accuracy Target pressure > -120 mbar max. Δ 5 %

Target pressure < -120 mbar max. Δ 10 %

Operating time Continuous operation

Runtime in battery operation ca. 18 h, depending on the strain of the motor

Service life 5 years

Item number (REF) 100567-3

* The information provided may differ depending on the altitude above sea level, the prevailing

air pressure and the air temperature.


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7.2 ASSKEA ped S

Flow rate* (measuring point at

suction tube nozzle) max. 8 l/min (low flow)

Vacuum -60 mbar to -350 mbar (in steps of 5 mbar) (medium vacuum)

Conversion factor: 1 kPa ~ 7.5 mmHg; 1 kPa ~ 10 mbar

Canister Disposable secretion canister system (1,000 ml);

reusable secretion canister system (1,000 ml)

Suction tube Disposable suction tube with step connector, Ø 4 mm (internal),

length: 180 cm, sterile (REF: 100712)

Nominal voltage of the

power supply unit

In: AC 100 – 240 V~ / 50 – 60 Hz / 350 – 150 mA

In (UL only): 120 Vac / max. 350 mA / 50 – 60 Hz

Out: DC 12 V / 1.25 A

Maximum load current 1.25 A

Permissible input voltage 12 V

Power consumption at 12 V 15 W

Degree of protection

pursuant to IEC 60601-1 Type BF

Risk classification

pursuant to 93/42/EEC, IX IIa

Protection class

pursuant to IEC 60601-1 II

IP degree of protection IP22

CE marking CE0843

UL marking

Sound emission

Operation: 35 dB (A)

High priority alarm: 53 dB (A)

Low priority alarm: 51 dB (A)

Ambient conditions

Transport/Storage

ambient temperature: -25 °C to +60 °C

relative humidity: up to 93 %, non-condensing


Operation

ambient temperature: +5 °C to +40 °C

relative humidity: 15 % to 93 %, non-condensing


Battery, rechargeable 7.4 V; 4400 mAh (lithium ion battery)

Charging time if battery is empty 6 - 7 hours

Charging time if battery is

approximately 50 % full 3 - 3.5 hours

Power supply unit FRIWO FW7555M/12, FRIWO Gerätebau GmbH

Dimensions basic device

(H x W x D) 290 mm x 259 mm (canister: + 100 mm) x 130 mm

Weight (basic device) 2.2 kg

Pressure measurement accuracy Target pressure > -120 mbar max. Δ 5 %

Target pressure < -120 mbar max. Δ 10 %

Operating time Continuous operation

Runtime in battery operation ca. 10 - 20 h, depending on the strain of the motor

Service life 5 years

Item number (REF) 100566-3

* The information provided may differ depending on the altitude above sea level, the prevailing

air pressure and the air temperature.


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7.3 EMC information

Medical electrical equipment is subject to special precautionary measures

regarding electromagnetic compatibility and must be installed and operated in

accordance with the EMC information provided in the accompanying

documentation!

Portable and mobile RF communication equipment can affect medical electrical

equipment!

The use of accessories and spare parts (incl. transformers and cables) not

recommended by ASSKEA GmbH may increase the emission of electromagnetic

interference or reduce the electromagnetic immunity of the devices. Damage

caused by using non-recommended accessories and spare parts or by

improper use is not covered by warranty in any case.

Only use original ASSKEA accessories and spare parts!

The use of the recommended accessories and spare parts (incl. transformers

and cables) with other devices than the ASSKEA ped M resp. ASSKEA ped S

may increase the emission of electromagnetic interference or reduce the

electromagnetic immunity. Damage caused by using recommended

accessories and spare parts with other devices or by improper use is not

covered by warranty in any case.

Only use the accessories and spare parts with the devices ASSKEA ped M and

ASSKEA ped S.

The devices ASSKEA ped M and ASSKEA ped S must not be used directly

adjacent to or stacked with other devices. If operation adjacent to or stacked

with other devices is necessary, monitor the devices ASSKEA ped M and

ASSKEA ped S in this configuration to verify proper operation!

The devices ASSKEA ped M and ASSKEA ped S meet the requirements of IEC 60601-1-2/

EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”. Electromagnetic

interference is therefore reduced to a minimum.

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Table 1

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The devices ASSKEA ped M and ASSKEA ped S are intended for operation in the electromagnetic

environment specified below. The customer or the user of the ASSKEA ped M resp.

ASSKEA ped S must ensure that it is operated in such an environment.

Emissions measurement Compliance Electromagnetic Environment –

Guidance

RF emissions pursuant to CISPR 11 Group 1

The devices ASSKEA ped M and

ASSKEA ped S use RF energy for

their internal function only.

Their RF emissions are therefore

very low and not likely to cause

interference in nearby electronic

equipment.

RF emissions pursuant to CISPR 11 Class B The devices ASSKEA ped M and

ASSKEA ped S are appropriate

for use in all facilities incl.

private residences and those

directly connected to the public

power supply network that

supplies buildings used for

residential purposes.

Harmonic emissions pursuant to

IEC 61000-3-2 Class A

Voltage fluctuations/flicker emissions

pursuant to IEC 61000-3-3 Complies

Table 2

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


environment specified below. The customer or user of the ASSKEA ped M resp. ASSKEA ped S

must ensure that it is used in such an environment.

Immunity tests IEC 60601 test level Compliance level

Electromagnetic

Environment –

Guidance

Electrostatic

discharge (ESD)

pursuant to

IEC 61000-4-2

±6kV contact

discharge

±8kV air discharge

±6kV contact

discharge

±8kV air discharge

Floors should be

made of wood,

concrete or ceramic

tile. If floors are

covered with

synthetic material,

the relative humidity

must be at least 30%.

Fast transient

electrical

disturbances/bursts

pursuant to

IEC 61000-4-4

±2kV for power supply

lines

±1kV for input and

output lines

±2kV for power supply

lines

±1kV for input and

output lines

Main supply voltage

should be of the

same quality as in a

typical commercial,

living or hospital

environment.

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Immunity tests IEC 60601 test level Compliance level

Electromagnetic

Environment –

Guidance

Interference

voltages/surges

pursuant to

IEC 61000-4-5

±1kV voltage

differential mode

±2kV common mode

±1kV voltage

differential mode

±2kV common mode

Main supply voltage

should be of the


typical commercial,

living or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines pursuant to

IEC 61000-4-11

<5% UT (>95% dip

of UT) for ½ period

40% UT (60% dip

of UT) for 5 periods

70% UT (30% dip


<5% UT (>95% dip

of UT) for 5 s

<5% UT (>95% dip

of UT) for ½ period

40% UT (60% dip


70% UT (30% dip


<5% UT (>95% dip

of UT) for 5 s

Main supply voltage

should be of the


typical commercial,

living or hospital

environment. If the

user of the

ASSKEA ped M resp.

ASSKEA ped S

requires continued

operation during

mains power

outages, it is

recommended to

power the devices

from an

uninterruptible

power supply or a

battery.

Magnetic fields at

power frequency

(50/60 Hz) pursuant

to IEC 61000-4-8

3 A/m 3 A/m

Power frequency

magnetic fields

should be at levels

characteristic for a

typical location in a

typical commercial,

living or hospital

environment.

Note: UT is the AC mains voltage prior to the application of the test levels.

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Table 3

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


environment specified below. The customer or user of the ASSKEA ped M resp. ASSKEA ped S

must ensure that it is used in such an environment.

Immunity tests IEC 60601 test

level Compliance level

Electromagnetic Environment –

Guidance

Conducted RF

disturbances

pursuant to

IEC 61000-4-6

Radiated RF

disturbances

pursuant to

IEC 61000-4-3

3 Veff

150 kHz to

80 MHz

3 V/m

80 MHz to

2.5 GHz

3 Veff

3 V/m

Portable and mobile RF

communications equipment

should be used no closer to any

part of the ASSKEA ped M resp.

ASSKEA ped S incl. cables, than

the recommended separation

distance calculated from the

equation applicable to the

frequency of the transmitter.

Recommended separation

distance:

d = 1.2 √P

d = 1.2 √P for 80 MHz to 800 MHz

d = 2.3 √P for 800 MHz to 2.5 GHz

Where P is the maximum output

power rating of the transmitter in

watts (W) according to the

specifications of the transmitter

manufacturer and d is the

recommended separation

distance in meters (m).

The field strength of fixed RF

transmitters should be lower

than the compliance levelb in

each frequency range as

determined by an

electromagnetic site surveya.

Interference is possible in the

vicinity of devices bearing the

symbol shown below.

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NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures,

objects and people. a Field strengths from fixed transmitters, such as e.g. base stations for radio telephones and

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment with

respect to fixed RF transmitters, an electromagnetic site survey should be considered. If the

measured field strength in the location in which the devices ASSKEA ped M and

ASSKEA ped S are used exceeds the applicable RF compliance levels above, the devices

should be monitored to verify proper operation. If abnormal performance is observed,

additional measures may be necessary, such as re-orienting or relocating the devices.

b The field strength should be lower than 3 V/m above the frequency range from 150 kHz to

80 MHz.

Table 4

Recommended protection ratio between portable and mobile RF communications equipment

and the ASSKEA ped M resp. ASSKEA ped S

The devices ASSKEA ped M and ASSKEA ped S are intended for operation in an

electromagnetic environment in which the radiated RF disturbances are controlled. The

customer or the user of the ASSKEA ped M resp. ASSKEA ped S can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the ASSKEA ped M resp. ASSKEA ped S as

recommended below, according to the maximum output of the communications equipment.

Rated power of

the transmitter

(W)

Protection ratio depending on the frequency of the transmitter (m)

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

d= 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended

protection ratio d in meters (m) can be determined using the equation applicable to the

frequency of the transmitter, where P is the maximum output power rating of the transmitter

in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures,

objects and people.

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8 Ordering information

8.1 ASSKEA ped M

Item number Description PU

100419 Power supply unit FRIWO FW7555M/12 (incl. all country adapters) 1

100696 Disposable secretion canister (250 ml) with step connector 30

100571 Carrying bag for ASSKEA ped M 1

8.2 ASSKEA ped S

Item number Description PU

disposable secretion canister system

100663 Disposable canister system (1,000 ml) incl. suction tube with

step connector 1

100000 External canister “Bag” 1

100002 Disposable liner “OneWay” (1,000 ml) 60

100267 Holder for external canister “Bag” 1

100280 Connecting tube 1

100712 Disposable suction tube with step connector (sterile) 10

reusable secretion canister system

100752 S6 reusable secretion canister system with disposable suction tube

with step connector (sterile) 1

100279 Reusable secretion canister 1

100199 S6 reusable secretion canister incl. lid 1

100205 S6 lid for reusable secretion canister 1

100278 Ball for overflow protection 3

100283 Tube mount (holding ring with tube clamp) 1

100194 External bacterial filter 5

100712 Disposable suction tube with step connector (sterile) 10

other accessories

100419 Power supply unit FRIWO FW7555M/12 (incl. all country adapters) 1

100013 Double filter system replacement set (DFS®

) 1

100282 Rinsing bottle 250 ml 1

100294 S6 tube connector 5

100222 S6 fingertip 5

100295 Carrying bag for ASSKEA suction devices 1

100288 Universal bed holder 1

100346 Variable holder for pipe and rail systems 1

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9 Publishing information

Created and published by:

ASSKEA GmbH

Haßlocher Straße 9

99189 Gebesee

GERMANY

Contact details:

Phone: +49-36201-5797-0

Fax: +49-36201-5797-33

E-Mail: [email protected]

www.asskea.de

instruction for use asskea ped m and asskea ped s

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